1. Field of the Invention
The present inventions relate to adaptors for use with intubated patients, and more particularly to novel multiple port access adaptors which may be used with a variety of different medical treatment devices simultaneously. Such treatment devices may include those designed for ventilation, aspiration, monitoring, visualizing, imaging, sampling and therapeutic delivery devices which are used on intubated patients.
2. State of the Art
There are a variety of different circumstances under which a person may be intubated. In intubation, an artificial airway, such as an endotracheal tube, is placed in the upper respiratory system of a patient to facilitate respiration. In some circumstances, such as surgery, the artificial airway is temporary and is used for anesthesia and proper ventilation and oxygenation. In many other situations, however, the endotracheal tube will be left in the patient for a prolonged period of time. With many traumatic accident victims, for example, the artificial airway will remain in place to sustain mechanical ventilation for the life of the patient.
Respiratory patient care has changed dramatically over the past three decades. Advances in medical technology have greatly increased the number of medical devices which are available for addressing problems associated with respiratory care. For example, if an endotracheal tube is to be left in place for more than a brief period of time, it is critical that respiratory secretions be periodically removed. This is most often accomplished with the use of a respiratory suction catheter which is advanced into the endotracheal tube. As the suction catheter is withdrawn, a negative pressure is applied to the interior of the catheter to draw mucus and other obstructions from the patient""s respiratory system.
Advanced medical devices which are available for use in respiratory care are not limited to endotracheal suction catheters. Improvements have been made in devices, such as bronchoscopes, which are used for visualizing the patient""s respiratory system. Other advances have facilitated the introduction of catheters to provide medical fluids to and from the lungs. Yet other advances have facilitated the sampling of respiratory tissues and secretions, therapeutic delivery of medication and other procedures.
The availability of these advanced medical devices has greatly improved the quality of life for those who must be intubated. Procedures today are generally less discomforting to the patient and are more efficacious. A dilemma is presented, however, in providing access to each of a number of medical devices to the patient at the same time. Traditionally, if a certain respiratory treatment device was needed, the patient was removed from other devices until the procedure was completed.
An extreme example of this practice is present in the use of open suction catheters. Until the 1980s, each time the patient""s respiratory system needed to be suctioned, it was common to disconnect the patient""s artificial airway from the manifold and ventilator tubes which supplied the patient with air. Interference with the air supply to the patient, even if only for a few seconds, was often severely distressing to the patient. These problems were initially overcome in the invention disclosed in U.S. Pat. No. 3,991,762 to Radford.
Radford developed what is commonly referred to as a closed suction catheter system. In a closed suction catheter system, a catheter is maintained within a protective sleeve which is attached to a manifold which also receives the tubing of the ventilator which delivers air to the patient""s lungs. When suctioning is desired, the catheter is advanced through the manifold and into the artificial airway. Negative pressure is then applied to the catheter and secretions within the patient""s respiratory system are evacuated.
The Radford system and its successors are advantageous in that they allow the patient""s ventilation to continue throughout the suctioning procedure. Additionally, they do not require the closed circuit to be broken (i.e. opened to outside air) for each suctioning procedure.
It is highly desirable to have these closed suction catheter systems attached to the endotracheal tube or other artificial airway of the patient. Doing so in the conventional manner, however, requires the closed suction catheter system to be disconnected from the patient to allow use of other devices such as bronchoscopes, oxygen supplementation catheters, tissue sampling devices, and the like. The endotracheal catheter system must then be reattached once the other device is no longer needed.
Breaking the circuit in this manner increases the risk of nosoccomial infections and increases the risk that clinicians will come into contact with mucus and other secretions of the patient. Additionally, it consumes time which the clinician could use to treat other patients.
In order to alleviate the safety and productivity issues, numerous attempts have been made to develop multiple port adaptors for use with endotracheal tubes. While not an exhaustive analysis of the configurations which have been set forth in the art, FIGS. 1A and 1B show typical attempts to provide a multi-port adaptor for use with endotracheal tubes and are discussed in detail below.
The adaptors of the prior art fall into two general categoriesxe2x80x94fixed and rotatable. In the fixed category, as shown in FIGS. 1A, the adaptor, generally indicated at 10, is typically made from a single piece of rigid material, such as acrylic or polypropylene. The adaptor 10 forms a generally T-shaped, elbow-like housing 14 with a first barrel 18 having an open distal end 18a forming a first, distal port to the housing 14. The interior surface 22 of the first barrel 18 forms a distal channel for receiving the proximal end of an endotracheal tube (not shown).
A fourth barrel 60 providing a fourth port 66 extends from the housing 14 on a side of the housing opposite the second barrel 26. The fourth port 66 allows for a second catheter assembly 70 to be used with the housing 14. As shown in FIG. 1A, the catheter assembly is configured to provide medical fluids directly into and from the patient""s lungs. To this end, a catheter 74 of the catheter assembly 70 is connected to an oxygen source 20.
A third port 34 is formed by a third barrel 38 which is disposed along a common axis with the first barrel 18. The orientation of the third barrel 38 facilitates the advancement of a catheter 42 of an endotracheal suction catheter assembly, generally indicated at 46, through the third and first barrels 34 and 18, respectively. The catheter 42 may thus be advanced down the endotracheal tube and used to suction mucus and other secretions from the patient""s respiratory system.
If desired, a lavage port 50 can be provided on the third barrel 38 to facilitate cleaning of the catheter 42. Most such catheter assemblies, however, include a lavage port for cleaning.
A fourth barrel 60 providing a fourth port 64 extends from the housing 14 on a side of the housing opposite the second barrel 26. The fourth port 64 allows for a second catheter assembly 70 to be used with the housing 14. As shown in FIG. 1A, the catheter assembly is configured to provide medical fluids directly into and from the patient""s lungs. To this end, a catheter 74 of the catheter assembly 70 is connected to an oxygen source 78.
The configuration of shown in FIG. 1A is a significant improvement over the prior configurations which required the endotracheal suction catheter assembly 46 to be removed prior to use of another device. The housing 14, however, has a disadvantage. In order to operate both the first and second catheter assemblies, or other devices, at least one of the assemblies must be brought or taken out of alignment with the long axis of the housing (i.e. the axis along which the first and third barrels 18 and 38 are disposed). Thus, at least one of the instruments advanced through the manifold must bend to enter the endotracheal tube. For many instruments, such as bronchoscopes, forced bending is undesirable because it increases mechanical wear and distortion. Additionally, instruments commonly have mucus or other secretions on them as they are withdrawn. Instead of carrying the secretion to the proximal ends of the housing (i.e. the third or fourth ports) where the mucus may be easily removed, the mucus may be scraped off in the first barrel 18. The mucus may reenter the patient through the endotracheal tube, may work its way down the ventilation circuit, or may remain in the adaptor 14 and serve as a medium for microbial growth.
FIG. 1B shows yet another attempt to solve the problems associated with obtaining access to the endotracheal tube for multiple instruments. An adaptor housing, generally indicated at 114, is provided with a distal, first barrel 118 having a port formed at the distal end 118a and a distal channel 122 for receiving the proximal end of an endotracheal tube. A second barrel 126 extends laterally from the first barrel 118 and forms a second port 130. A swivel structure 132 may be placed in the port 130 to provide a rotatable attachment between the housing 114 and the wye adaptor of a ventilation circuit (not shown).
As with the embodiment in FIG. 1A, a third barrel 138 extends along a common axis with the first barrel 118. The third barrel 138 includes an opening 134, but the opening does not form a port in that it is not exposed. Rather, a circular flange 140 is disposed about the opening 134. A circular cap 144 is configured to engage and rotate about the circular flange 140. A fourth barrel 148 and a fifth barrel 152 are disposed on the cap 144 so that rotation of the cap alternatively aligns the fourth barrel 148 and the fifth barrel 152 with the opening 134 in the third barrel 138. Thus, the fourth barrel 148 forms a third port 156, and the fifth barrel 152 forms a fourth port 164. Seals 168 may be provided to maintain a substantially airtight seal between the fourth and fifth barrels 148 and 152 and the remainder of the housing 114. A lavage port 162 may also be provided.
In use, a permanent instrument, such as a closed endotracheal suction catheter 168 is usually attached to one port, while the other port is provided with a cap 172 so that the port can be used with a temporary instrument, such as a bronchoscope, without leaving the interior of the housing open. Failing to cover or close the ports subjects both the clinician and the patient to increased risks of cross-contamination.
The configuration shown in FIG. 1B is advantageous in that it allows the port in use to be in axial alignment with the channels extending through the first and third barrels 118 and 138 and axial with the endotracheal tube opening. Thus, a catheter or other instrument is not required to bend as it is passed through the housing 114. Unfortunately, the embodiment shown in FIG. 1B is relatively expensive to make, in that it has several parts which must be molded and then assembled. Additionally, it can be somewhat cumbersome to use, and the ports can be inadvertently rotated, thereby causing misalignment.
Thus, there is a need for a multiple port adaptor which enables a catheter or other instruments to be advanced in a substantially straight line regardless of which port is being used. There is also a need for such a device which is inexpensive and easy to use.
It is an object of the present invention to provide an improved multiple port adaptor which is easy to use and relatively inexpensive.
It is another object of the invention to provide a multiple port adaptor which does not force catheters or other instruments to be bent as they are passed through the adaptor.
It is yet another aspect of the present invention to provide a multiple port adaptor in which the various ports can be used simultaneously, if necessary.
It is still yet another aspect of the present invention to provide a multiple port adaptor which is formed from a single piece of material.
The above and other objects of the invention are realized in specific illustrated embodiments of a multiple port adaptor including an adaptor body having distal end with a distal port, and at least two proximal portions in communication with the distal end, each of the proximal portions forming a proximal port. Unlike the prior art, the adaptor body is made of a flexible, preferably resilient, material such as silicone or polyvinyl chloride with sufficient plasticizers added to impart flexibility.
Rather than requiring instruments to bend or rotating barrels into and out of position, the adaptor body allows the clinician to align the desired proximal port with the distal port simply by manipulating the adaptor body. Such manipulation requires little additional dexterity because it is common practice for the clinician to hold the proximal end of the endotracheal tube, or the adaptor itself, when performing a procedure.
In accordance with one aspect of the invention, the adaptor body is formed as an offset wye, with the two proximal channels being axially offset approximately 30 degrees. One of the proximal channels may be configured for attachment to a xe2x80x9cpermanentxe2x80x9d device, such as a closed suction catheter assembly, while the other channel would be configured for use with a xe2x80x9ctemporaryxe2x80x9d device, such as a bronchoscope. When an instrument is advanced through one of the proximal channels, it would be in alignment with the distal channel without any manipulation of the adaptor body. If the other proximal channel were used, it could be placed in alignment with the distal channel by manipulating the proximal end of the adaptor body into a desired position which is 30 degrees offset from the original position.
In accordance with another aspect of the invention, a wye could be formed with each of the proximal channels being offset by the same amount, i.e. 15 degrees. By slightly manipulating the adaptor body, either of the proximal channels could be placed in alignment with the distal channel.
In accordance with still yet another aspect of the present invention, the adaptor body could be made with three or more proximal channels. By manipulating the adaptor body, any of the proximal channels could be substantially aligned with the distal channel.
In accordance with still yet another aspect of the present invention, the adaptor body could be made of a rigid material which is attached to a flexible joint or material, such as a popoid cylinder which would allow the adaptor body to pivot in the position necessary to place a desired proximal channel in alignment with the distal channel.
In accordance with still another aspect of the present invention, a retaining mechanism may be provided adjacent the adaptor body. The retaining mechanism would allow the resilient adaptor body to be held in a position in which a desired proximal channel is aligned with the distal channel to facilitate conducting a procedure through that proximal channel. Once completed, the retaining mechanism could be released and the adaptor body returned to its normal position.
In accordance with still yet another aspect of the present invention, one or more of the proximal channels can have a sealing mechanism disposed therein to maintain positive end expiratory, pressure (PEEP) regardless of whether the proximal channel is being used for a procedure.